Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks. Our fast-track request service identifies previously requested and redacted documents for quick access.
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FDA EIR Summary – North China Pharmaceutical Huasheng Co. (FEI: 3003001488)
Regular price $69.00 USDRegular priceUnit price / per -
FDA EIR Request – Arizona Nutritional Supplements at Multiple Locations (Chandler, Miami Lakes, Hialeah)
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FDA Complete File for FEI #3015213291 – CDER Communications & Hennepin Healthcare Inspection (04/09–04/23/2019)
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FDA Complete File for FEI #3015212514 – CDER Communications & Hennepin Healthcare Inspection (04/10–04/26/2019)
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FDA BLA Review – BLA 761139/S‑028 (Approved April 5, 2024)
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FDA Biologics License Application – Romosozumab Background for Bone, Reproductive & Urologic Drugs Advisory Committee (Published 01/16/2019)
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FDA Type C Meeting Minutes & Teleconference – Referenced in BLA 761143 Supplement 024 (02/27/2023 & 03/22/2023)
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FDA BIMO Inspections Dataset – Category Type & Classification
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FDA Assessment Reports & Approval Letter – ANDA 209611 (Linaclotide Capsules)
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FDA Scientific Basis of Approval & Supplement 4 – ANDA 209954 (Albuterol Sulfate Aerosol, Lupin)
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FDA eCTD Submission Documents – Ciprofloxacin Ophthalmic Solution, USP 0.3% (ANDA 077689, Sequences 0001–0006)
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FDA Chemistry & Clinical Pharmacology Reviews – ANDA #211369 Drug Approval Package
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FDA Summary Basis of Approval – Fluticasone Propionate Nasal Spray, 50mcg/Spray (ANDA 76504 & 207957, HIKMA PHARMACEUTICALS USA INC)
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FDA Clinical Assessment – ANDA 206298 Diclofenac Sodium Gel 3%
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FDA Active ANDAs Directory – Manufacturer, Drug Name, Facility Location & ANDA Number (As of 06/25/2024)
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FDA Summary Basis of Approval – Lidocaine Hydrochloride Jelly (2%), ANDA A201094, Sagent Pharmaceuticals Inc.
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FDA Approval Letter & Routing Summary – ANDA 211558 for Tromethamine Solution (Approved December 9, 2024)
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FDA Tentative Approval – Estradiol Valerate & Dienogest Tablets (ANDA 202999, DR REDDYS LABS SA)
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FDA Packaging Insert & Labeling – Hydrocortisone Sodium Succinate for Injection, ANDA 214050 (Applicant: CIPLA LTD)
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FDA Approval Routing Summary – ANDA 207792 for Isotretinoin Capsules (Approved Sep 29, 2017)
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FDA Approval Routing Summary – ANDA 202099 for Isotretinoin Capsules 30 mg (Approved Feb 23, 2015)
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FDA Approval Routing Summary – ANDA 076485 for Isotretinoin Capsules 30 mg (Approved Aug 25, 2015)
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FDA Approval Routing Summary – ANDA 211568 for Isotretinoin Capsules (Approved Aug 29, 2023)
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FDA Tentative Approval Letter – ANDA 216799 for Letermovir Tablets 240 mg & 480 mg (Zydus Pharms USA Inc.)
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FDA Approval Letters – ANDA 214112 Tentative (1/11/2023), ANDA 211107 Effective (8/05/2024), ANDA 211198 Effective (4/18/2023) for Macitentan
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FDA Tentative Approval Letter – ANDA 216915 for Nilotinib Capsules (Issued 01/12/2023)
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FDA Tentative Approval Letter – ANDA 215123 for Nilotinib Capsules (Issued 05/12/2022)
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FDA PI Labeling – ANDA 040491: Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL (Updated 06/05/2024)
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FDA Supplement S-004 – ANDA 207957
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FDA ANDA Documentation – Acarbose Tablets (ANDA #091343; Ownership, Transfer, 356h Form & Submissions)
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FDA Approved Label Information – ANDA#210924 & ANDA#209253
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FDA Product Approval Documentation & Supplements – A0216348
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FDA Actavis ANDA 204982 – Phentermine & Topiramate Extended-Release Capsules Review Summary
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FDA ANDA Approval Routing Sheets & Letters for Viibryd – Teva (ANDA 208212), Invagen (ANDA 208200), Alembic (ANDA 208202), Accrod (ANDA 208209)
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FDA Adverse Event Complaints – Epinephrine Chloride Solution 10m/10ml (1mg/ml) Vasoconsitor for Topical Application, NDC 54288-123-01
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FDA FAERS Case Reports – Lutathera (Lutetium Lu 177 Dotatate) Adverse Effects/Toxicities (Groups of 12 Cases, 2024)
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